The Absolute Effect / Evidence index

Adjuvant / Postoperative · Phase III open-label randomized; N=174 women with stage III HER2-negative HRD breast cancer. Intensified alkylating chemotherapy + autologous stem-cell rescue vs contemporary chemotherapy followed by olaparib. Primary endpoint OS. · Four-year OS 77.0% vs 76.4%

SUBITO

Clinical question: Does intensified alkylating chemotherapy with stem-cell rescue improve survival over standard chemotherapy followed by olaparib in stage III HRD HER2-negative breast cancer?

Four-year OS 77.0% vs 76.4%; HR 1.11 (95% CI 0.57–2.17; P=0.37); no survival advantage for intensified chemotherapy. · Registry:

Design, population and treatment

Phase III open-label randomized; N=174 women with stage III HER2-negative HRD breast cancer. Intensified alkylating chemotherapy + autologous stem-cell rescue vs contemporary chemotherapy followed by olaparib. Primary endpoint OS.

Key efficacy outcome

77 · intervention
76.4
77 · comparator
No NNT: no efficacy advantage demonstrated.

Grade 3–4 thrombocytopenia 99% vs 19%, neutropenia 95% vs 61%, anaemia 62% vs 41%; serious TEAEs 47% vs 26%.

Safety and absolute effect

4-year OS (%)

https://pubmed.ncbi.nlm.nih.gov/42372741/

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/S1470-2045(26)00131-2